Innovation and Collaboration

It seems that most new proposals for improving public health and the nation's economy offer ways to reduce the cost and time of drug development and thus speed more new products to patients. This is particularly evident in the rash of "pro-innovative" approaches for testing and regulating medical products proposed as add-ons to Food and Drug Administration (FDA) user fee legislation moving forward on Capitol Hill.

Typical of the broader look, the "Bioeconomy Blueprint" issued by the White House Office of Science and Technology Policy in April maps out how biotechnological advances can promote economic growth, create new jobs, and improve health. A strong undercurrent in this grab bag of ideas is that innovation will flourish by eliminating unnecessary regulatory roadblocks. Thus it supports revisions in rules governing human subject research and proposes to tap into FDA's vast repository of drug safety and efficacy data to speed drug development.

New drugs from old

Cost Contentions

The Blueprint also backs public-private partnerships supporting translational research by the National Institutes of Health (NIH) to find new ways to prevent and cure disease. Such an initiative was launched last month by Health and Human Services Secretary Kathleen Sebelius, who joined NIH Director Francis Collins and three pharma companies to announce a pilot that would "rescue" compounds abandoned by industry. Pfizer, AstraZeneca, and Eli Lilly agreed to launch the program by working with researchers on "repurposing" drugs sitting on their shelves.

The initiative will start with the new National Center for Advancing Translational Sciences (NCATS) funding $20 million in grants next year to support promising research proposals, along with templates for agreements on dealing with intellectual property. The companies will provide researchers with the compounds and relevant data, while retaining rights to their products. Scientists from academia, non-profits, or biotech companies will be able to publish study results and negotiate licenses on new discoveries. The program intentionally ruled out seeking additional uses for approved drugs, as those raise more complex IP issues. NIH is soliciting comments on the templates, which are key to speeding up negotiations among all parties and making the program work. A list of compounds available for research will be published in a few months, and initial grants awarded next spring.

The manufacturers see the NIH program as a way to extend similar arrangements they already have with individual research institutes, including AstraZeneca's partnership with the United Kingdom's Medical Research Program. The selected compounds have been tested for safety in early clinical trials, but lacked sufficiently robust results to support larger studies. The hope is that these abandoned products will do better with new targets and new indications.